Sr. Director, eCompliance – Global Quality Technical Operations

PCI Pharma Services•Philadelphia, PA

17h

About The Position

This role is responsible for defining and maintaining the Global Computerized System Validation (CSV) Master Plan, transitioning the organization towards Computer Software Assurance (CSA) models. It involves establishing standardized Software Development Life Cycle (SDLC) requirements, overseeing cloud-based platforms and IT infrastructure validation, and serving as the corporate custodian for Data Integrity. The position also involves developing audit trail review programs, leading data mapping and risk assessments, providing technical compliance oversight for MasterControl implementation, establishing the compliance framework for AI and advanced analytics, collaborating on Operational Technology (OT) integration, leading change management for 'Compliance by Design', acting as the Quality liaison to Global IT for new technology deployment, providing site support during system deployments, serving as the lead SME for eCompliance and Data Integrity during inspections, developing and monitoring quality metrics, and performing external benchmarking. This position may require extra hours and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules is required. Attendance to work is an essential function of this position. Performs other duties as assigned by leadership. Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Supervises 1-10 employees.

Requirements

Bachelor’s degree in Information Technology, Computer Science, Quality Assurance, or a related scientific/technical discipline is required.
Minimum of 10 years of progressive experience in an IT Quality, eCompliance, or Computer Systems Validation role within a GxP environment.
Proven experience managing large-scale organizational change and digital system implementations.
Deep technical expertise in GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and GDPR.
Exceptional ability to influence cross-functional stakeholders and translate complex technical requirements into actionable compliance strategies.
Strong communication skills are essential for interfacing with both technical teams and regulatory inspectors.
Bachelor's Degree in a related field and/or 10+ years related experience and/or training.
College Level Mathematical Skills
Ability to perform the most complex computer tasks and operate various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Highest Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete/abstract variables.
Other Required Skills.

Nice To Haves

Master's Degree (M.A.) in related field and/or 5+ years related experience or training.
Ability to work independently and/or part of a team.
Ability to effectively present information to various people as the job requires.
Ability to identify and resolve problems in a timely manner.

Responsibilities

Define and maintain the Global Computerized System Validation (CSV) Master Plan, transitioning the organization toward Computer Software Assurance (CSA) models.
Establish standardized Software Development Life Cycle (SDLC) requirements for all GxP systems, overseeing the full lifecycle from User Requirement Specifications (URS) and Configuration Specifications to Performance Qualification (PQ) and formal decommissioning.
Partner with Global IT to ensure that cloud-based platforms (SaaS/PaaS) and underlying IT infrastructure are qualified and maintained in a validated state, including oversight of vendor audits and Service Level Agreements (SLAs).
Serve as the corporate custodian for Data Integrity, ensuring all digital records meet ALCOA+ principles.
Develop and implement standardized protocols for the periodic review of system audit trails.
Lead comprehensive data mapping exercises across global sites to identify high-risk data flows and implement technical controls.
Provide technical compliance oversight for the enterprise-wide rollout of MasterControl QMS and eBatch Record (eBR).
Establish the compliance framework for AI-assisted batch release and predictive modeling pilots.
Collaborate with MS&T and Engineering to validate the integration of shop-floor systems with enterprise-level data architectures.
Lead organizational change efforts to embed "Compliance by Design" into the company culture.
Act as the primary Quality liaison to Global IT for the deployment of new technologies, ensuring that cybersecurity protocols and disaster recovery plans meet GxP requirements.
Provide "boots-on-the-ground" assistance to site leadership during complex system deployments.
Serve as the lead Subject Matter Expert (SME) for eCompliance and Data Integrity during regulatory inspections.
Develop and monitor Key Performance Indicators (KPIs) related to system health, validation status, and data integrity compliance.
Monitor the evolving international regulatory landscape to ensure PCI Pharma remains at the forefront of global eCompliance trends.
Interviewing, hiring, and training employees.
Planning, assigning, and directing work.
Appraising performance.
Rewarding and disciplining employees.
Addressing complaints and resolving problems.